ORPHENADRINE CITRATE ER- orphenadrine citrate tablet, extended release

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

ORPHENADRINE CITRATE (UNII: X0A40N8I4S) (ORPHENADRINE - UNII:AL805O9OG9)

থেকে পাওয়া:

Advanced Rx Pharmacy of Tennessee, LLC

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

INDICATIONS AND USAGE Orphenadrine citrate extended-release tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions. Orphenadrine citrate extended-release tablets are contraindicated in patients with glaucoma, pyloric or duodenal obstruction, stenosing peptic ulcers, prostatic hypertrophy or obstruction of the bladder neck, cardio-spasm (mega-esophagus) and myasthenia gravis. Orphenadrine citrate tablets are contraindicated in patients who have demonstrated a previous hypersensitivity to the drug. Orphenadrine has been chronically abused for its euphoric effects. The mood elevating effects may occur at therapeutic doses of orphenadrine.

পণ্য সারাংশ:

Orphenadrine citrate extended-release tablets 100 mg are round, white to off-white tablets, debossed NL4 on one side and plain on the other side and are supplied as: Bottles of 30 Tablets NDC: 80425-0117-01 Bottles of 60 Tablets NDC: 80425-0117-02 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured For Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 PI4800000204 Rev: 06/2017

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

ORPHENADRINE CITRATE ER- ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE
ADVANCED RX PHARMACY OF TENNESSEE, LLC
----------
ORPHENADRINE CITRATE ER 100MG TABLETS
1. DESCRIPTION
Orphenadrine citrate is the citrate salt of orphenadrine. It occurs as
a white, crystalline
powder having a bitter taste. It is practically odorless; sparingly
soluble in water, slightly
soluble in alcohol. The chemical name of orphenadrine citrate is
(±)-N,N-Dimethyl-2-[(o-
methyl-α-phenylbenzyl)oxy]ethylamine citrate (1:1) having molecular
formula
C18H23NO•C6H8O7 and molecular weight of 461.51. It has the following
structural
formula:
Each tablet for oral administration contains 100 mg orphenadrine
citrate. Each
Orphenadrine citrate extended- release tablet contains the following
inactive ingredients:
hydroxypropyl methylcellulose, lactose monohydrate and magnesium
stearate.
2. CLINICAL PHARMACOLOGY
The mode of therapeutic action has not been clearly identified, but
may be related to its
analgesic properties. Orphenadrine citrate does not directly relax
tense muscles in man.
Orphenadrine citrate also possesses anti-cholinergic actions.
3. INDICATIONS AND USAGE SECTION
INDICATIONS AND USAGE
Orphenadrine citrate extended-release tablets are indicated as an
adjunct to rest,
physical therapy, and other measures for the relief of discomfort
associated with acute
painful musculoskeletal conditions.
4. CONTRAINDICATIONS
Orphenadrine citrate extended-release tablets are contraindicated in
patients with
glaucoma, pyloric or duodenal obstruction, stenosing peptic ulcers,
prostatic
hypertrophy or obstruction of the bladder neck, cardio-spasm
(mega-esophagus) and
myasthenia gravis. Orphenadrine citrate tablets are contraindicated in
patients who have
demonstrated a previous hypersensitivity to the drug.
5. WARNINGS
Some patients may experience transient episodes of light-headedness,
dizziness or
syncope. Orphenadrine may impair the ability of the patient to engage
in potentially
hazardous activities such as operating machinery or driving a motor
ve